A Study to Evaluate How VI-0521 Affect Psychomotor Performance in Healthy Overweight and Obese Subjects.

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine how VI-0521 affect speed and reaction time on specific tasks that require eye and hand coordination, compared to placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: VIVUS, Inc.
• Collaborator: MDS Pharma Services
• Treatments: Ethanol

Criteria

Inclusion Criteria:

• Written consents;

• Adequate contraception from screening through 28 days after the last dose of study drug for female subjects;

• Healthy obese or overweight subjects with BMI between 27 and 35.

Exclusion Criteria:

• History of glaucoma or any past or present use of medications to treat increased intraocular pressure;

• Current use of any tobacco products, including cigarettes, cigars, pipes, or chewing tobacco, or use within the three months prior to screening;

• History of drug abuse during the three years prior to screening;

• History of alcohol abuse, or excessive alcohol consumption, or describes themselves as non-users of alcohol;

• Current depression of moderate or greater severity, or any presence or history of suicidal behavior or active suicidal ideation

• More than one lifetime episode of major depression;

• Currently working night shifts at a job;

• On average consumes greater than two cups of coffee or xanthine-containing beverages per day (>200 mg/day) within the two weeks prior to screening;

• Any use of dietary, herbal, and/or fitness/body-building supplements (with the exception of vitamins) within one month prior to screening;

• Aspartate aminotransferase or alanine aminotransferase >2.5 x ULN;

• Serum creatinine ≥1.5 mg/dL for men or ≥1.4 mg/dL for women.